A Study to Find a Safe Dose of Volasertib Given in Addition to Standard Salvage Chemotherapy in Children (Age 3 Months to Less Than 18 Years) With Acute Myeloid Leukaemia, in Whom Front-line Chemotherapy Failed

• Status: Withdrawn
• Trial end date: 2018-09-01
• Target enrollment: 0
• Participant gender: All

Summary

This is an open-label, dose-escalating trial to evaluate the MTD and/or dose to be used for further development by evaluation of DLT in course 1 and the safety of volasertib when added to standard intensive salvage chemotherapy with DNX-FLA in paediatric patients with AML after failure of first-line therapy. Furthermore, data on efficacy and PK/PD of volasertib in paediatric patients with AML when added to standard intensive salvage chemotherapy will be collected.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim

Criteria

Inclusion criteria:

• Patients 3 months to <18 years of age at the time of informed consent

• Patients with AML after failure of the front-line intensive AML therapy

• Lansky score at screening >=50 for patients from 3 months to <12 years

• Karnofsky score at screening >=50 for patients from 12 to <18 years

• Use of highly effective methods of birth-control, if sexually active

• Parents/legal guardians and patients have given written informed consent and informed assent suitable for the respective age group

Exclusion criteria:

• Down syndrome

• Acute promyelocytic leukaemia and treatment-related AML

• QTc prolongation

• LVSF <30%

• Cardiac disease and/or dysfunction

• Active uncontrolled infection

• HIV infection, acute or chronic hepatitis

• Inadequate lab parameters

• Impaired renal function

• Pregnancy or nursing

• Further exclusion criteria apply